Engineer, Quality Assurance

Judge Group, Inc.; Mahwah (NJ); On-site; USD 56,000 - 59,000; Full time

Job summary

The Judge Group, Inc. is seeking a Quality Assurance Engineer in Mahwah, NJ. This contract position focuses on quality engineering support, process control, testing and inspection to ensure products are defect-free and perform as designed.

You will lead FAI strategy, PPAP, change control, equipment and process validations, and update SOPs and risk management documentation. Strong communication and MS Office skills are required; medical device knowledge is a plus.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field.

Responsibilities

• Develop and implement methods and procedures for process control, process improvement, testing and inspection.
• Lead First Article Inspection (FAI) strategy development, execution and approvals.
• Support Production Part Approval Process (PPAP) and change control processes.
• Perform equipment and process validations.
• Update SOP and Risk Management documentation.

Skills

Quality engineering

Change management

Communication skills

Problem solving

Team collaboration

Education

Bachelor's degree in Biomedical Engineering or Mechanical Engineering or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Location: Mahwah, NJ Salary: $41.00 USD Hourly – $43.00 USD Hourly Description:

Title: Engineer, Quality Assurance

Location: Mahwah, NH

Duration: 12 Month Contract

About the Role

As a Quality Engineer you will provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions.

You will be tasked with developing and implementing methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.

You will be expected to support:

• First Article Inspection (FAI) strategy development, execution, and approvals.

• Production Part Approval Process (PPAP)

• Change control processes and change impact assessments

• Equipment and Process validations

• SOP and Risk Management documentation updates and reviews

• And more

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience.

You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulations and standards.

Expected Qualifications:

Bachelor’s Degree – Biomedical Engineering, Mechanical Engineering or related field

2 years of experience in industry required

Knowledge of Change Management and Quality Management Systems (QMS) principles.

Firm understanding of Med Device concepts highly desirable.

Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.

Excellent communication skills and attention to detail.

Good understanding of engineering and quality concepts / theories.

High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.

Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.

Be willing to work as part of a multi-site team.

Have knowledge of Risk Based and statistical concepts is desirable.

Problem solving and analytical skills.

Be able to build strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.

Ability to be the voice of Quality when dealing cross functionally.

Excellent English (both oral and written).

Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.